Cleared Traditional

LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE (K870582) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870582 · Strato Medical Corp. · General Hospital
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Apr 1987
Decision
71d
Days
Class 2
Risk

K870582 is an FDA 510(k) clearance for the LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on April 23, 1987 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Strato Medical Corp. devices

Submission Details

510(k) Number K870582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1987
Decision Date April 23, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K870582.
CHECK VALVE
K881052 · Baxter Healthcare Corp · May 1988
SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH
K880482 · Baxter Healthcare Corp · Mar 1988
CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
K873894 · Travenol Laboratories, S.A. · Nov 1987
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.
K870940 · Travenol Laboratories, S.A. · Mar 1987
SECONDARY SET LOCK
K864338 · Travenol Laboratories, S.A. · Nov 1986
SOLUTION ADMINISTRATION SET
K860541 · Travenol Laboratories, S.A. · Mar 1986